MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	0500316E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem Description
A hemodialysis clinic reported once hemodialysis (hd) treatment was started there was blood visible in the dialysate line as well as a blood leak alarm.The blood pump was stopped, and blood was not returned to the patient.The patient was stable and completed treatment on another machine.There was no injury to patient.The machine was bleached twice and tested negative for blood at the dialysate line and the drain line.Additional information was requested but has not been received to date.
Additional Manufacturer Narrative
The complainant mentioned the dialyzer was a f160 and the lot number was ¿17su-01003.¿ this lot number is invalid as it does not exist.An sap search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.No dialyzer product was delivered to the patient¿s dialysis unit in this time frame.As such, an additional sap search was performed to obtain the last delivered lot number with the reported catalog number.As a result, lot number 15nu06006 was found to be the last lot delivered to the customer.A record review was completed for 15nu06006.An investigation of the device manufacturing records was conducted by the manufacturer.There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event.The review included a check of non-conformance, rework, labeling, process controls, and any other occurrence in production potentially related to the reported complaint.The lot passed all release criteria.
Event or Problem Description
A hemodialysis clinic reported once hemodialysis (hd) treatment was started there was blood visible in the dialysate line as well as a blood leak alarm.The blood pump was stopped, and blood was not returned to the patient.The patient was stable and completed treatment on another machine.There was no injury to patient.The machine was bleached twice and tested negative for blood at the dialysate line and the drain line.Additional information was requested but has not been received to date.

• Brand Name: OPTIFLUX 160NRE DIALYZER FINISHED ASSY
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• MDR Report Key: 6915969
• Report Number: 1713747-2017-00319
• Device Sequence Number: 13781151
• Product Code: KDI
• UDI-Device Identifier: 00840861100187
• UDI-Public: 00840861100187
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0500316E
• Device Lot Number: 15NU06006
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1